CN102131452B - System and method for enhanced maneuverability - Google Patents

System and method for enhanced maneuverability Download PDF

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Publication number
CN102131452B
CN102131452B CN200980133275.XA CN200980133275A CN102131452B CN 102131452 B CN102131452 B CN 102131452B CN 200980133275 A CN200980133275 A CN 200980133275A CN 102131452 B CN102131452 B CN 102131452B
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piston head
balloon catheter
distal balloon
stress level
gastrointestinal tract
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CN102131452A (en
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约拉姆·布鲁姆
埃兰·绍尔
兰·门德勒维茨
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GI View Ltd
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GI View Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/273Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147Holding or positioning arrangements
    • A61B1/00148Holding or positioning arrangements using anchoring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015Control of fluid supply or evacuation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/32Devices for opening or enlarging the visual field, e.g. of a tube of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0122Steering means as part of the catheter or advancing means; Markers for positioning with fluid drive by external fluid in an open fluid circuit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1042Alimentary tract
    • A61M2210/1064Large intestine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

The present invention relates to an imaging apparatus comprising an elongated carrier adapted to be inserted through a proximal opening of a gastrointestinal (GI) tract lumen; a piston head, coupled to a distal portion of the carrier, and configured to: be inflated so as to form and maintain a pressure seal with a wall of the GI tract lumen, and be advanced distally through the GI tract in response to pressure from a fluid pressure source; a distal balloon coupled to the carrier distal to the piston head and configured and operable to be inflated so as to dilate the lumen thereby creating a working space; and a control unit, configured and operable to control simultaneously a pressure level within the piston head and a pressure level within the distal balloon. The control comprises maintaining a constant level of pressure within the piston head thereby maintaining said pressure seal and cyclically modulating the level of pressure within the distal balloon facilitating the distal advancement of the piston head within the GI tract lumen.

Description

The system and method that operability strengthens
Technical field
The present invention relates in general to pressure-propelled system, and this system is applicable to for example gastrointestinal (GI) road imaging of body cavity.
Background technology
Known many imaging devices that is used to form the medical imaging of body cavity (for example gastrointestinal (GI) road).For example, endoscopy is widely used in tissue visualization, is tissue photograph, and extracts sample etc. from lesion.
Pipe in human body may have convolution chamber configuration.For example gastrointestinal tract is from oral cavity, and through esophagus, Stomach duodenum and small intestinal, small intestinal is folding many times to fit in the long tube in abdominal part.Small intestinal is connected with large intestine, and large intestine, from caecum, little cryptomere valgus, then succeeded by ascending colon, transverse colon, descending colon and second shape (S shape) colon, and leads to rectum.These body cavitys may suffer pathological changes, affect anatomical structure or the structure of body cavity.For example, may be by hardening or existing wound tissue or tumor to cause the inner chamber of normal configuration narrow, shrink or close.
Traditional colonoscopy utilization is inserted the thin tubulose fibre-optical probe in large intestine (colon) by rectum.Conventional imaging endoscope for this process comprises the flexible pipe with optical fiber light-guiding part, and this optical fiber light-guiding part is guided to illumination light from external light source the far-end of endoscope, at this far-end, illuminates and treats checked region (that is, tissue, inaccessible object).
Be mainly because bending and the fragility of large intestine and ileum, the colonoscopy of even tool penetrance is all limited to end and the colon of small intestinal (ileum).Endoscope and colonoscopy check that the hurtful risk of patient body is little but harm is large, and for example duodenum or ileum perforation, especially develop into late period in disease, when surrounding tissue has died down or degenerated.
The people's such as Cabiri PCT communique WO 05/065044 has described a kind of equipment using together with bio-compatibility fluid pressure source, this equipment comprises and is suitable for inserting through the elongated bearing part of the proximal openings of body cavity and the piston head that is connected to the distal portion of this bearing part, and this patent is incorporated herein by reference.Described piston head is suitable for sealing with the wall mineralization pressure of body cavity after bearing part inserts body cavity, and is suitable for to distal advancement, passing through body cavity in response to the pressure from fluid pressure source.This equipment is configured to make fluid be beneficial to and make piston head distal advancement from body cavity is flowed out at the endoceliac position away from piston head by being beneficial to.This equipment also comprises near the optical system distal portion that is connected to bearing part, and this optical system has far-end and near-end.
In some embodiments of this PCT application, this equipment is described to comprise auxiliary piston head, and this auxiliary piston head is connected to bearing part in the position near far-end piston head.Described auxiliary piston head is described to be suitable for being inflated, thereby forms and directly contact and keep this contact with the wall of colon.At bearing part, be positioned at endoceliac at least one time point, far-end piston head is described as and is suitable in response to the pressure from fluid pressure source with the auxiliary piston head that expanded at least partly side by side in collapsed state, and passes through colon to distal advancement.At bearing part, in endoceliac at least another time point, auxiliary piston head is described as the far-end piston head that is suitable in response to the pressure from fluid pressure source and expansion at least partly side by side in collapsed state, and passes through colon to distal advancement.
For example, this PCT applies for that having described described system can finally run into obstacle or sharp turn.In this case, described proximal piston head is described as and expands and described far-end piston head is described as and collapses.In this structure, charging fluid is described as the fluid pressure that produces the proximal lateral act on described proximal piston head and likens to for the fluid pressure of the distal side of described proximal piston head larger.This pressure differential is described as together with described bearing part and advances described proximal piston head to far-end.This distal movement surmounts obstacles the far-end piston head of collapsing.
This system is described as and continues it in endoceliac distal movement, until proximal piston head runs into obstacle.Now, far-end piston head is described as expansion, and proximal piston head is described as collapses.Charging fluid is described as the fluid pressure that produces the proximal lateral act on described far-end piston head and likens to for the fluid pressure on the distal side of described far-end piston head larger.Described pressure differential is described as be in body cavity and advances described system to far-end, and the proximal piston head of collapsing is surmounted obstacles.This circulation is described as where necessary and repeatedly repeats as far as possible.
Summary of the invention
Be necessary to provide a kind of improved imaging medical treatment device, this imaging medical treatment device passes through gastrointestinal tract to distal advancement, and the operability that is especially used as strengthening enters the imaging device in lower gastrointestinal tract.This demand is relevant to following factors.Lower gastrointestinal tract is comprised of rectum and large intestine or colon.Colon extends upward from right lower quadrant, crosses the width of health under diaphragm, and along the left side of abdominal part to downward-extension, then before being connected with anus with rectum, the mode with regression is coiled into ring.Because of the flexible nature of endoscope shaft and the sagging character of colon, be difficult to utilize soft endoscope to large intestine intubate.For some, sigmoid colon may be grown and be unfixing except its mesentery very much, therefore because sigmoid colon when promoting endoscope by sigmoid colon often forms ring and may extremely difficultly carry out intubate to it.Some anatomic regions (for example sigmoid colon junction, splenic flexure and hepatic flexure of colon) only due to its tortuosity be difficult to by.Because being coiled into annular in sigmoid colon, endoscope aggravates the problem through this region.
Therefore splanchnoscopy is a kind of difficult technology that just can be proficient in after having carried out hundreds of time inspection.Rapidly pipe is inserted to enteral and crosses whole colon until the ability of caecum is the technical ability that only minority splanchnoscopy person just has.For the difficult public survey running in splanchnoscopy, show, in 15% case, procedure failure, among this owing to can not reaching colon or can not make colon be regarded as seen invalid.In 35% case, because the pain that process duration extends and patient experiences is regarded as difficulty.Other investigation shows, reaches 29% case and is considered to technical and has difficulties.
Endoscope is generally 100 to 150 centimeter length, and can be inserted in arbitrary end of digestive system.Conventionally, this device has the specific design feature being suitable for for the health opening of endoscope's insertion.Endoscope is promoted from bottom, and utilizes external control to be guided through tortuous path.
The invention provides a kind of imaging device of novelty, it is removable by the imaging device of body cavity that this imaging device is generally.
In some embodiments, elongated bearing part is inserted through the proximal openings (" near-end " and " far-end " should be understood to be with respect to doctor) in gastrointestinal (GI) chamber, road.The piston head that is connected to the distal portion of bearing part is inflated, thereby seals with the wall mineralization pressure in gastrointestinal tract chamber and keep this wiper seal.Described piston head passes gastrointestinal tract in response to the pressure from described fluid pressure source to distal advancement.Distal balloon catheter is coupled to described bearing part away from described piston head.Control unit is keeping the pressure-tight stress level circulation simultaneously making in described distal balloon catheter.Conventionally, when the distal movement of described piston head is obstructed, described control unit makes described stress level circulation.In some embodiments, when the distal movement of described piston head is not obstructed, described control unit additionally makes the described stress level circulation in described distal balloon catheter.
It is therefore to be understood that for object of the present invention, the obturation that term " wiper seal " should be interpreted as at least a portion place of body cavity with its conventional sense advances described piston head to far-end.
Some embodiments of the present invention provide a kind of imaging system, and this imaging system is pushed into through body cavity by fluid pressure, for example gastrointestinal (GI) road.With reference to gastrointestinal tract, describe embodiments of the present invention herein, but should be understood that these embodiments are not limited to use in gastrointestinal tract, but also can be used for other body cavity.
Therefore the equipment using together with a kind of fluid pressure source of and bio-compatible is provided according to the embodiment of the present invention, and this equipment comprises: elongated bearing part, and this bearing part is suitable for being inserted through the proximal openings in gastrointestinal (GI) chamber, road; Piston head, this piston head is connected to the distal portion of described bearing part, and is configured to: be inflated, thereby seal and keep this wiper seal with the wall mineralization pressure in gastrointestinal tract chamber, and to distal advancement, pass gastrointestinal tract in response to the pressure from fluid pressure source; Distal balloon catheter, this distal balloon catheter connects with described bearing part away from described piston head, and is constructed and can be operable to and be inflated, thereby makes the expansion of gastrointestinal tract chamber, produces thus work space; And control unit, this control unit is constructed and can be operable to the stress level simultaneously controlled in described piston head and the stress level in described distal balloon catheter, described control comprises the constant pressure level keeping in described piston head, keep thus the described wiper seal between described piston head and the wall in gastrointestinal tract chamber and periodically regulate the described stress level in described distal balloon catheter, be beneficial to described piston head at gastrointestinal tract intracavity to distal advancement.
Should be understood that other body cavity of harmonization of the stomach in gastrointestinal tract has highly movable wall, is easily shifted when power is applied to it.They also expand and shrink very effectively and with various circulations.At any time, body cavity all can be opened or closed, but the most often in collapsed state.Therefore, distal balloon catheter of the present invention is constructed and can be operable to and makes body cavity expansion, to form thus work space in body cavity, is beneficial to the imaging that piston head advances and is beneficial to inner chamber.By periodically regulating pressure in distal balloon catheter, realize the expansion of body cavity.Therefore sacculus is formed into as work space and stably keeps this space in body cavity.This causes the frictional force that whole equipment advances along body cavity to reduce.
It shall yet further be noted that make piston head to distal advancement must with the wall Continuous Contact of body cavity, therefore can not apply to piston head the periodic adjustment of supercharging.
In one embodiment, described piston head and described distal balloon catheter are constructed and are arranged with spaced apart separating, and described distance, in about 1mm to 50mm scope, is preferably 10mm.
In one embodiment, the hardness of the part connecting between described piston head and described distal balloon catheter of at least described bearing part is selected as in the scope of about 30 to 60 Shore A levels.This part being connected between described piston head and described distal balloon catheter of described bearing part can be separating part or the integral part of bearing part.The flexibility that should be understood that described bearing part is to treat the key character of the equipment selected suitably.On the one hand, in order to insert in gastrointestinal tract, this equipment must have enough flexibilities; On the other hand, in order to advance in gastrointestinal tract and not crooked, described bearing part must have enough rigidity.Therefore, the hardness of at least a portion of described bearing part must be selected as inserting and advancing along gastrointestinal tract.Described hardness can be variable along described bearing part.For example, spring-like member can be introduced in described bearing part, to control its hardness.
In one embodiment, described control unit is constructed and can be operable to the hindered motion of the described piston head of identification, and in response to the hindered motion identifying, makes the stress level circulation in described distal balloon catheter.
In one embodiment, described control unit is configured to independently make the stress level circulation in described distal balloon catheter with any indication of the hindered motion of described piston head.
In one embodiment, at piston head to during distal advancement, substantially as long as when described piston head is kept with wiper seal between the wall in gastrointestinal tract chamber, described control unit just can make the stress level in described distal balloon catheter circulate.
In one embodiment, described control unit is configured to receive the input of the hindered motion of the described piston head of indication that user generates, and makes the stress level circulation in described distal balloon catheter in response to described input.
In one embodiment, described piston head is formed at diameter under swelling state in the scope of about 25mm to 100mm.
In one embodiment, the stress level circulation time in described control unit makes described distal balloon catheter, the maximum gauge of described distal balloon catheter is in the scope of about 10mm to 65mm.
In one embodiment, the described control unit cycle in the scope of about 0.5 second to 10 seconds according to length that is configured to makes the stress level circulation in described distal balloon catheter, and described length is especially in the scope of about 2 seconds to 6 seconds.
In one embodiment, the described control unit cycle in the scope of about 1.5 seconds to 4 seconds according to length that is configured to makes the stress level circulation in described distal balloon catheter.
In one embodiment, described control unit is formed at a plurality of cycle periods the minimum pressure level set of described distal balloon catheter is less than to 1mbar and/or substantially for 0mbar for being less than 10mbar, being preferably.
In one embodiment, described control unit is formed at a plurality of cycle periods the maximum pressure levels of described distal balloon catheter is set as in about scope of 20 to 100mbar.In one embodiment, described equipment comprises suction source, and this suction source is configured to from described distal balloon catheter pumping fluid, and described control unit is configured to by controlling described suction source, the stress level in described distal balloon catheter be circulated.
In one embodiment, described control unit is configured to by allowing passively fluid to discharge the stress level in described distal balloon catheter is circulated from described distal balloon catheter.
In one embodiment, described control unit is constructed such that the stress level circulation in described distal balloon catheter, therefore to make selectively near-end and/or the far-end of described sacculus collapse or expand, and according to the clinical effectiveness of expectation, regulate the size of described work space.
In one embodiment, described equipment comprises: at least first fluid pressure source and second fluid pressure source; The first path, this first path is communicated with described the first pressure source and described piston head fluid, for described piston head is expanded; And alternate path, this alternate path is communicated with described the second pressure source and described distal balloon catheter fluid; Make described control unit by driving described the first pressure source to keep wiper seal between described piston head and the wall in gastrointestinal tract chamber and by driving described the second pressure source periodically to regulate the stress level in described distal balloon catheter, thereby side by side and independently control stress level in described piston head and the stress level of described distal balloon catheter.
In one embodiment, described equipment comprises image acquisition equipment, and this image acquisition equipment is arranged on described bearing part away from described distal balloon catheter, is constructed and can be operable to gastrointestinal tract imaging.Described distal balloon catheter is constructed and can be operable between gastrointestinal tract and described image acquisition equipment and produces space, is beneficial to described gastrointestinal tract imaging.
Should be understood that when described image acquisition equipment is positioned to contact with body cavity, be difficult to the tissue that imaging is relevant.Therefore, described sacculus produces space between the linked groups of the front end that holds image acquisition equipment away from described imaging device.
In addition, should be understood that for the described bearing part that described image acquisition equipment is installed be flexible, therefore described image acquisition equipment is attracted downwards due to gravity.Therefore, described distal balloon catheter is constructed and is operable to described bearing part is for example placed in, near the central authorities of described gastrointestinal tract (colon), and this gastrointestinal diameter is greater than the diameter of described bearing part, and keeps the machine-direction oriented of bearing part.The wall of colon in panoramic view is therefore almost equidistant apart from image acquisition equipment, to reduce the required depth of field and to simplify exposure.
In one embodiment, described distal balloon catheter diameter under swelling state is less than the diameter of described piston head.
In other embodiment, described distal balloon catheter and the sealing of gastrointestinal tract mineralization pressure, so that described equipment can be to distal advancement.
According to the embodiment of the present invention, also provide a kind of method, the method comprises, mineralization pressure sealing between piston head and the wall in gastrointestinal (GI) chamber, road, and described piston head is arranged near distal balloon catheter; By the outer surface to described piston head, apply fluid pressure, and make described piston head and described distal balloon catheter pass through gastrointestinal tract chamber to distal advancement; And the pressure-tight while keeping between described piston head and the wall in gastrointestinal tract chamber, periodically regulates the stress level in described distal balloon catheter, so that the expansion of gastrointestinal tract chamber produces and is beneficial to the imaging work space that described piston head advances thus.
In one embodiment, in mineralization pressure sealing between described piston head and the wall in gastrointestinal tract chamber, be included in mineralization pressure sealing between described piston head and the wall in gastrointestinal tract chamber, the distal face of described piston head is disposed in proximal end face to near-end apart from the described distal balloon catheter distance in the scope of about 1mm to 50mm.
In one embodiment, described method also comprises the hindered motion of identifying described piston head, wherein, periodically regulates stress level in described distal balloon catheter to comprise in response to the hindered motion identifying and periodically regulates the stress level in described distal balloon catheter.
In one embodiment, described method also comprises the input of the hindered motion that receives the described piston head of indication that user generates, and wherein, periodically regulates stress level in described distal balloon catheter to comprise in response to described input and periodically regulates described stress level.
In one embodiment, periodically regulate stress level in described distal balloon catheter to comprise and as long as any indication of the hindered motion of described piston head is irrelevant and/or substantially when the wiper seal between described piston head and the wall in gastrointestinal tract chamber is kept during described piston head distal advancement, the stress level in described distal balloon catheter is circulated.
In one embodiment, periodically regulate the stress level in described distal balloon catheter to comprise the stress level regulating in described distal balloon catheter, making the maximum gauge at distal balloon catheter described in a plurality of cycle periods is 10mm to 65mm.
In one embodiment, periodically regulate the stress level in described distal balloon catheter to comprise at least one in following situations: according to length, to be the stress level in distal balloon catheter described in the periodic adjustment of 0.5 second to 10 seconds (being specially the length of 2 seconds to 6 seconds); In a plurality of cycle periods, the stress level in described distal balloon catheter is set in minima at least 0.5 second, and in a plurality of circulations, set in maximum at least 10 seconds; In a plurality of cycle periods, the minimum pressure level set in described distal balloon catheter being become to be less than 10mbar, especially for being less than 1mbar, is especially basic 0mbar; In a plurality of cycle periods, the maximum pressure levels in described distal balloon catheter is set for and is greater than 20mbar, especially for being greater than 60mbar.
In one embodiment, periodically regulate the stress level in described distal balloon catheter to comprise actuating suction source, with from described distal balloon catheter pumping fluid.
In one embodiment, periodically regulating stress level in described distal balloon catheter to comprise allows fluid to discharge from described distal balloon catheter passively.
Accompanying drawing explanation
Figure 1A to 1B is arranged in piston head in the gastrointestinal tract of object and the schematic diagram of distal balloon catheter according to an embodiment of the invention;
Fig. 2 A to 2B is according to an embodiment of the invention schematic diagram of the distal balloon catheter in collapsed state and swelling state respectively; And
Fig. 3 A to 3B is the curve chart illustrating according to the pressure in an embodiment of the invention periodic adjustment distal balloon catheter.
The specific embodiment
Referring now to Figure 1A, this figure is according to the schematic diagram of the embodiment of the imaging device 100 of an embodiment of the invention.According to an embodiment of the invention, imaging device 100 comprises control unit 25 and is arranged in piston head 20 and the distal balloon catheter 22 in the gastrointestinal tract chamber 24 of object.Piston head 20 connects with the distal portion of bearing part, thereby and be configured to be inflated with the wall mineralization pressure in gastrointestinal tract chamber and seal and keep this wiper seal, and in response to the pressure from fluid pressure source to distal advancement through gastrointestinal tract.Distal balloon catheter 22 is connected to bearing part away from piston head, and structure can be operable to and be inflated, thereby makes the expansion of gastrointestinal tract chamber, is formed into thus picture work space.Control unit 25 structures also can be operable to, by keep piston head internal pressure level constant with keep thus wiper seal between piston head and gastrointestinal tract chamber wall and by periodically regulate stress level in distal balloon catheter be beneficial to make piston head at gastrointestinal tract intracavity to distal advancement, thereby the stress level in while control piston head and the stress level in distal balloon catheter.
Elongated bearing part 28 inserts in this gastrointestinal tract chamber by the proximal openings in gastrointestinal (GI) chamber, road.In the concrete but non-sex-limited embodiment of Figure 1A, in the proximal openings of guide 26 insertion objects body cavitys, for example gastrointestinal tract chamber 24, and elongated bearing part 28 inserts in body cavity by the hole in guide.Be configured to the image acquisition equipment 30 of gastrointestinal tract chamber imaging conventionally away from distal balloon catheter 22, to be arranged on bearing part 28.
Should be understood that distal balloon catheter also constructs and can be operable between gastrointestinal tract and image acquisition equipment and produce space, be beneficial to gastrointestinal tract imaging.
With reference to Figure 1B, Figure 1B shows the enlarged drawing of a part for imaging device 100.Bearing part 28 comprises piston head path 34, and this piston head path is communicated with piston head 20 fluids, and is connected with the bio-compatibility fluid source 32 of supercharging, such as but not limited to pressurized air, the CO for piston head 20 is expanded 2or the source of water (not shown).In some embodiments, guide 26 is formed with the source path 29 being connected with same source 32 or another source.
For some application, piston head expansion fluid pressure source is adjusted to no matter piston head changes in response to the diameter in gastrointestinal tract chamber 24 change in volume producing how all to keep the pressure substantially constant in piston head 20.For example, piston head be configured to when this piston head during in swelling state diameter be 25mm to 100mm.
Discharge pipe 38 can through or around piston head 20 (and through or around distal balloon catheter 22), this discharge pipe has the opening 40 away from piston head 20, fluid can be discharged to outside by this opening 40.That is, the near-end of discharge pipe 38 makes to arrive outside through the fluid drainage of guide 26.
Power supply pipe 42 (for example, comprising electric wire, optical fiber etc.) can pass bearing part 28, for being connected with image acquisition equipment 30.
In some embodiments, fluid supply tube 44 passes bearing part 28, and is connected with fluid source (not shown), this fluid source is for example the water of supercharging, for near the region clean image acquisition equipment 30, or is communicated with discharge pipe 38, for cleaning gastrointestinal tract chamber 24 self.
For example, by make fluid (air) pass into gastrointestinal via path 34, near the position of piston head, to piston head 20, exert pressure, make like this piston head pass gastrointestinal tract and advance.During piston head advances, discharge pipe 38 will be discharged to outside due to the front of piston head and then the pressure that gathers.Conventionally by produce pressure reduction with opposite way, initiatively to make piston head 20 make piston head pass gastrointestinal tract to near-end propelling together with bearing part 28, to near-end, recall.From the charging fluid (for example air) of another (for example the 3rd) fluid pressure source (not shown) by through or around the pressure of piston head 20, apply the distal side that pipe is introduced to piston head 20.Therefore distal balloon catheter is independent of piston head by different fluid pressure sources and is controlled.
Optionally, discharge pipe 38 applies pipe as pressure during recalling.The distal side that charging fluid generation acts on piston head 20 likens to for the larger fluid pressure in the proximal lateral of piston head 20, thus to near-end propelling piston head and bearing part.During advancing by gastrointestinal tract at piston head and/or recalling, 30 pairs of gastrointestinal tract imagings of imaging device.
In some embodiments, another path 46 through or around piston head 20.Equipment 100 can have another fluid pressure source (not shown) being communicated with another path 46 and distal balloon catheter 22 fluids.Control unit 25 simultaneously and control independently via path 46 and flow into the fluid stream distal balloon catheter 22 from another fluid pressure source.Fluid leads to outside via path 46 by guide 26 and removes from distal balloon catheter 22.
In some embodiments, the first path is to distal balloon catheter accommodating fluid, and alternate path is from distal balloon catheter removing fluids.Conventionally, the bio-compatibility fluid of fluid pressure source supply supercharging, such as but not limited to pressurized air, CO 2or water.For some embodiments, fluid is discharged from distal balloon catheter via path 46 with passive mode (that is, by allowing fluid to flow out outside body cavity).Alternatively, path 46 is connected to suction source, and this suction source is from distal balloon catheter pumping fluid on one's own initiative.For example, control unit 25 control and suck sources.
Referring now to Fig. 2 A to 2B, Fig. 2 A to 2B is according to an embodiment of the invention schematic diagram of the distal balloon catheter 22 in collapsed state (Fig. 2 A) and swelling state (Fig. 2 B) respectively.In some embodiments, piston head 20 expands, thereby seals with the wall mineralization pressure in gastrointestinal tract chamber 24 and keep this wiper seal (example as shown in Figure 1A).As mentioned above, piston head passes gastrointestinal tract in response to the pressure from fluid pressure source to distal advancement.Control unit 25 (shown in Figure 1A) makes the stress level circulation in distal balloon catheter, keeps the wiper seal between piston head and described wall simultaneously.
In some embodiments, when the distal movement of piston head is subject to hindering, control unit makes the stress level circulation in distal balloon catheter.The motion (for example, being connected to the acceleration sensor of piston head by use) of control unit 25 identification piston heads 20, and make the stress level circulation in distal balloon catheter 22 in response to the parameter of the motion identifying.Alternatively or additionally, control unit receives the input that indicator piston head motion that user generates is obstructed, and makes the stress level circulation in distal balloon catheter in response to this input.For some application, the indication of the hindered motion of control unit and piston head independently makes the stress level circulation in distal balloon catheter.For example, at piston head, to during distal advancement, substantially as long as the wiper seal between piston head and gastrointestinal tract chamber wall is kept, control unit just can make stress level basic continous in distal balloon catheter and circulate.
For some application, the maximum dimension D 2 of distal balloon catheter 20 is 10mm to 65mm, and control unit 25 makes the stress level circulation in distal balloon catheter simultaneously.Distal balloon catheter 22 connects with piston head 20 by pipe 50 conventionally, and managing 50 can be separating part or the integral part of bearing part 28.In some embodiments, manage 50 and there is 30 to 38 Shore A hardness.Conventionally, in the embodiment that the maximum dimension D 2 of sacculus is 10mm to 50mm therein, managing 50 length L is 5mm to 30mm, and in the embodiment that the maximum dimension D 2 of sacculus is 50mm to 65mm therein, managing 50 length L is 20mm to 50mm.
In some embodiments, control unit is constructed such that the circulation of stress level in distal balloon catheter, to collapse selectively or far-end and/or the near-end (22A and 22B) of dilatation balloon.
Referring now to Fig. 3 A to 3B, Fig. 3 A to 3B illustrates the curve chart that the periodic pressure in distal balloon catheter 22 regulates according to an embodiment of the present invention.Fig. 3 A illustrates circulation in 4 seconds, according to this circulation, and balloon pressure under the minimum pressure of each circulation in 0mbar 2 seconds, and under the maximum pressure of each circulation in 25mbar 2 seconds.Fig. 3 B illustrates circulation in 8 seconds, according to this circulation, and balloon pressure under the minimum pressure of each circulation in 0mbar 4 seconds, and under the maximum pressure of each circulation in 50mbar 4 seconds.
Conventionally, when the advancing and/or recall interaction between the equipment of being subject to and gastrointestinal tract chamber and hinder of piston head 20, the periodic pressure in distal balloon catheter 22 regulates and is conducive to this and advances and/or recall.
Should be understood that by the outer surface to piston head and apply fluid pressure to produce pressure differential, this equipment has in response to the ability of recalling to near-end by body cavity from the pressure of fluid pressure source.From the charging fluid (for example air) of fluid pressure source via through or around the pressure of piston head 20, apply the distal side that pipe is drawn towards piston head 20.Optionally, discharge pipe 38 applies pipe as pressure during recalling.Charging fluid produces on the distal side that acts on piston head 20 and likens fluid pressure larger on the proximal lateral for piston head 20 to, thus to near-end propelling piston head and bearing part.Discharge pipe between the proximal lateral of piston head 20 and body cavity outside can help to produce pressure differential in piston head 20 both sides by applying suction actively or passively.During piston head is recalled, the stress level in distal balloon catheter is not periodically regulated, but make it remain on constant minimum pressure, thereby distal balloon catheter is expanded, to produce space between gastrointestinal tract and image acquisition equipment, this image acquisition equipment is arranged on bearing part and is beneficial to gastrointestinal tract to carry out imaging away from distal balloon catheter as previously discussed.The distal balloon catheter expanding can make image acquisition equipment be submerged in body cavity.
In some embodiments, equipment 100 comprises suction source (not shown), and this suction source is configured to from distal balloon catheter pumping fluid on one's own initiative.Control unit 25 is configured to by control and suck source, the stress level in distal balloon catheter be circulated.The stress level Cycle Length of suction source is within the scope of about 0.5 second to 5 seconds.
Alternatively or additionally, fluid is discharged from distal balloon catheter passively.Stress level Cycle Length in distal balloon catheter is within the scope of about 1.5 seconds to 10 seconds.In some embodiments, the stress level that this cycle makes distal balloon catheter in a plurality of circulations in minima about 0.5 to 4 second, and in a plurality of circulations in maximum about 0.5 to 4 second.
In some embodiments, the minimum pressure in a plurality of cycle period distal balloon catheter is less than 10mbar, for example, is less than 1mbar, for example, be 0mbar substantially.In some embodiments, the maximum pressure in a plurality of cycle period distal balloon catheter is greater than 20mbar, for example, be greater than 65mbar.
For example, distal balloon catheter is pulsed with about goal pressure of 50 to 60mbar.Can be several modes of operation: (1) circulation in about 0 to 6 second (being preferably 2 seconds) scope applies constant pressure.Then carry out active and collapse, and do not exert pressure in about 0 to 2 second.(2) by close passage, apply constant pressure 0 to 6 second (being generally 2 seconds) (in this case,, even if ambient pressure raises, sacculus is also uncontrolled or can not reduce its volume).Then carry out active and collapse, and do not exert pressure in about 0 to 2 second.(3) distal balloon catheter can again be collapsed immediately or expand (the fastest frequency).
Should be understood that as mentioned above, the bottom that gastrointestinal is connected with rectum is thin portion, wherein, and insertion and the expand difficulty of piston head in this thin portion.In order to address the above problem, by keeping constant stress level, diameter be significantly less than the diameter of piston head and before piston head, insert distal balloon catheter in body cavity inflatable and with the sealing of gastrointestinal tract mineralization pressure so that equipment can be to distal advancement.
In some embodiments, use distal balloon catheter to far-end driven plunger head and whole equipment.Then by being less than the pressure of the rear portion pressure (that is, acting on the pressure of the proximal lateral of piston head) of supply, piston head is expanded.Under this pattern, piston head is conventionally because the low pressure less than its ambient pressure is collapsed, but once observe leakage (for example, when distal balloon catheter and not mineralization pressure sealing of colon wall), rear portion pressure reduces rapidly (owing to leaking), and makes piston head and colon produce wiper seal.Therefore the ability that, system of the present invention is separated control piston head and distal balloon catheter makes it possible to carry out particularly when there is leakage between piston head and colon wall and essential this generic operation when the pressure drop of the proximal lateral of piston head.By utilizing this operator scheme, piston head is because ambient pressure decline volume increases, thereby can seal better with colon wall, further Leakage prevention.
It will be understood by those skilled in the art that and the invention is not restricted to the above content that specifically illustrates and describe.And scope of the present invention comprises combination and time combination of above-mentioned various features, and comprise by those skilled in the art read after above stated specification, can expect be not present in variants and modifications of the prior art.

Claims (16)

1. an imaging device, this imaging device comprises: elongated bearing part, this bearing part is suitable for being inserted into and through the proximal openings in gastrointestinal tract chamber; Piston head, this piston head connects with the distal portion of described bearing part, and is configured to: be inflated, thereby seal and keep this wiper seal with the wall mineralization pressure in gastrointestinal tract chamber, and to distal advancement, pass gastrointestinal tract in response to the pressure from fluid pressure source; Distal balloon catheter, this distal balloon catheter connects with described bearing part at far-end with respect to described piston head, and is constructed and can be operable to and be inflated, thereby makes the expansion of gastrointestinal tract chamber, forms thus work space; And control unit, this control unit is constructed and can be operable to the stress level simultaneously controlled in described piston head and the stress level in described distal balloon catheter, described control comprises the constant pressure level keeping in described piston head, keep thus described wiper seal and consecutive periods and regulate the stress level in described distal balloon catheter, be beneficial to described piston head at gastrointestinal tract intracavity to distal advancement.
2. equipment according to claim 1, wherein, described distal balloon catheter and described piston head arrange with the spaced apart structure that separates, described distance is in 1mm to 50mm scope.
3. equipment according to claim 1, wherein, described control unit is constructed and can be operable to the hindered motion of the described piston head of identification, and makes the stress level circulation in described distal balloon catheter in response to the hindered motion identifying.
4. equipment according to claim 1, wherein, described control unit is configured to receive the input of the hindered motion of the described piston head of indication that user generates, and makes the stress level circulation in described distal balloon catheter in response to described input.
5. equipment according to claim 1, wherein, the part connecting between described piston head and described distal balloon catheter of at least described bearing part is selected as hardness in the scope of 30 to 60 Shore A levels.
6. equipment according to claim 1, wherein, described piston head is formed at when swelling state diameter in the scope of 25mm to 100mm.
7. equipment according to claim 1, wherein, the diameter of described distal balloon catheter is in the scope of 10mm to 65mm.
8. equipment according to claim 1, wherein, the described control unit cycle within the scope of 0.5 second to 10 seconds according to length that is configured to makes the stress level circulation in described distal balloon catheter.
9. equipment according to claim 1, this equipment also comprises suction source, and this suction source is configured to from described distal balloon catheter pumping fluid, and described control unit is configured to by controlling described suction source, the stress level in described distal balloon catheter be circulated.
10. equipment according to claim 1, wherein, described control unit is configured to by allowing passively fluid to discharge the stress level in described distal balloon catheter is circulated from described distal balloon catheter.
11. equipment according to claim 1, wherein, described control unit is constructed such that the stress level circulation in described distal balloon catheter, to make selectively near-end and/or the far-end of described sacculus collapse or expand.
12. equipment according to claim 1, this equipment also comprises: at least first fluid pressure source and second fluid pressure source; The first path, this first path is communicated with described the first pressure source and described piston head fluid, for described piston head is expanded; And alternate path, this alternate path is communicated with described the second pressure source and described distal balloon catheter fluid; Make described control unit by driving described the first pressure source to keep wiper seal between described piston head and the wall in gastrointestinal tract chamber and by driving described the second pressure source periodically to regulate the stress level in described distal balloon catheter, thereby side by side and independently control stress level in described piston head and the stress level in described distal balloon catheter.
13. equipment according to claim 1, this equipment also comprises image acquisition equipment, this image acquisition equipment is constructed and can be operable to respect to described distal balloon catheter and be arranged on described bearing part at far-end, with to described gastrointestinal tract imaging.
14. equipment according to claim 13, wherein, described distal balloon catheter is constructed and can be operable between gastrointestinal tract and described image acquisition equipment and produces space, is beneficial to described gastrointestinal tract imaging.
15. equipment according to claim 1, wherein, described distal balloon catheter diameter under swelling state is less than the diameter of described piston head.
16. equipment according to claim 1, wherein, described distal balloon catheter and the sealing of gastrointestinal tract mineralization pressure, so that described equipment can be to distal advancement.
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